Safety and Efficacy of 25 mg/kg and 35 mg/kg vs 10 mg/kg Rifampicin in Pulmonary TB: A Phase IIb Randomized Controlled Trial

Perumal Kannabiran, Bhavani and Alangudi Palaniappan, Natarajan and Manoharan, Tamizhselvan and Paramasivam, Paulkumaran and Subramanyam, Balaji and Ramesh, PM and Natarajan, Saravanan and Ammayappan, Radhakrishnan and Ganesan, Mangalambal and Angamuthu, Dhanalakshmi and Chinnaiyan, Ponnuraja and Chandrasekaran, Padmapriyadarsini (2024) Safety and Efficacy of 25 mg/kg and 35 mg/kg vs 10 mg/kg Rifampicin in Pulmonary TB: A Phase IIb Randomized Controlled Trial. Safety and Efficacy of 25 mg/kg and 35 mg/kg vs 10 mg/kg Rifampicin in Pulmonary TB: A Phase IIb Randomized Controlled Trial, 11(3) (ofae03).

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Abstract

Globally, no trial data are available on head-to-head comparison between 10 mg/kg and 25/35 mg/kg rifampicin in treating pulmonary tuberculosis during study initiation. A multicentric, phase IIb randomized trial recruited 333 new culture-positive, drug-sensitive adult patients with pulmonary tuberculosis to compare safety and efficacy of high-dose rifampicin (R25/R35), against conventional dose (R10) given daily for 8 weeks followed by standard doses for 16 weeks. Main outcomes were treatment-emergent grade 3/4 adverse events (AEs) and time-to-culture conversion in liquid media, assessed by division of AIDS system for grading the severity of adverse events division of AIDS criteria and Kaplan-Meier methods.

Affiliation:	ICMR-National Institute for Research in Tuberculosis
Item Type:	Article
URI:	http://eprints.nirt.res.in/id/eprint/2151

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